CTRI Number |
CTRI/2014/06/004707 [Registered on: 26/06/2014] Trial Registered Prospectively |
Last Modified On: |
13/12/2014 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Vaccine |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A study to test the safety of a new H1N1 influenza vaccine in healthy volunteers |
Scientific Title of Study
|
A Randomized, Double-blind, Placebo-controlled, Clinical Trial to Evaluate the Immunogenicity and Safety of H1N1-09 Influenza Virus-Like Particle (VLP) Vaccine |
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Registry |
CRSC13001; Version-01, Protocol Amendment, Date 06/07/13 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Deepak Sawhney |
Address |
1389, Trasad Road, Dholka,
Ahmedabad
Ahmadabad GUJARAT 387810 India |
Phone |
02714-221481 |
Fax |
|
Email |
deepak.sawhney@cadilapharma.co.in |
|
Details Contact Person Scientific Query
|
Name |
Dr Deepak Sawhney |
Address |
1389, Trasad Road, Dholka,
Ahmedabad
GUJARAT 387810 India |
Phone |
02714-221481 |
Fax |
|
Email |
deepak.sawhney@cadilapharma.co.in |
|
Details Contact Person Public Query
|
Name |
Dr Deepak Sawhney |
Address |
1389, Trasad Road, Dholka,
Ahmedabad
GUJARAT 387810 India |
Phone |
02714-221481 |
Fax |
|
Email |
deepak.sawhney@cadilapharma.co.in |
|
Source of Monetary or Material Support
|
Cadila Pharmaceuticals Limited |
|
Primary Sponsor
|
Name |
Cadila Pharmaceuticals Limited |
Address |
Corporate Campus,
Sarkhej-Dholka Highway,
Village: Bhat, Ahmedabad – 382210,
Gujarat, India. |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 12 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr SK Sharma |
All India Institute of Medical |
Department of
Medicine, All India Institute of Medical
Sciences, Ansari Nagar, New Delhi-110029 New Delhi |
011-26594415
sksharma@aiims.ac.in |
Dr Sanjeev Rao |
Apollo – BGS Hospitals |
Dept of Medicine, Adichunchanagiri Road, Kuvempunagar,
Mysore – 570023, Karnataka, India Mysore |
9986051595
srgdec4@gmail.com |
Dr Ahrar Ahmed |
Apollo DRDO Hospital |
Dept of Medicine, DMRL Cross Roads, Kanchan Bagh,
Hyderabad-500058, Andhra Pradesh Hyderabad |
040-24342222
dr_aaf@yahoo.co.in |
Dr Pitambar Prusty |
Apollo Hospitals |
Dept. of Medicine, A unit of Apollo Hospitals Enterprises Limited,
Bhubaneswar – 751005, Orissa, India
Khordha |
8093060134
prustypita@rediffmail.com |
Dr Venkatasubramanian Ramasubramanian |
Apollo Hospitals |
Room No 16 & 17, 2nd floor,
Krishnadeep Chambers, Greams Lane,
Off Greams road,
Chennai-600006, Tamil Nadu, India Chennai |
044-28295045
idisdoc@gmail.com |
Dr Manoj Singh |
Apollo Hospitals International Limited |
Dept. of medicine, Bhat, GIDC Estate,
Gandhinagar – 382 428, Gujarat, India. Gandhinagar |
079-66701800
drmanojsingh@rediffmail.com |
Dr Asha Shah |
B.J. Medical College |
Dept. of Medicine, Civil Hospital, Ahmedabad- 380016,
Gujarat, India
Ahmadabad |
079-22983721
ashashah55@gmail.com |
Dr Alok Aggrawal |
Indraprastha Apollo Hospitals |
Dept of Medicine, Sarita Vihar, Delhi-Mathura Road,
New Delhi-110076
New Delhi |
011-26925825
aloc_doc2003@hotmail.com |
Dr Ashish Bavdekar |
KEM Hospital Research Centre, |
Dept of Medicine, KEM Hospital Research Centre,
Sardar Moodlier Road, Rasta Peth,
Pune-411011, Maharashtra, India Pune |
020-66037342
kemhre@vsnl.net |
DrSatyabrata Ganguly |
Medical College |
Department of Medicine, Medical College, #88,
College Street, Kolkata-700073
West Bengal, India
Kolkata |
033-22414901
dr_satyaganguly@yahoo.co.in |
DrSurendra Kumar |
Sardar Patel Medical College and P.B.M hospital |
Dept of Medicine, Sardar Patel Medical College and P.B.M hospital, Bikaner-334003, Rajasthan, India Bikaner |
0151-2226334
drsurendrakumar@rediffmail.com |
Dr Nithya Gogtay |
Seth GS Medical College & KEM Hospital |
Department of Clinical Pharmacology,
Seth GS Medical College & KEM Hospital,
Parel, Mumbai-400012, Maharashtra, India
Mumbai |
022-24133767
njgogtay@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 11 |
Name of Committee |
Approval Status |
Ethics comittee KEM hospital research centre Pune |
Approved |
Ethics comittee on clinical trial Apollo Hospital Delhi |
Approved |
Ethics comittee S P medical college and hospitals |
Approved |
Ethics Committee Apollo hospitals Bhubaneswar |
Submittted/Under Review |
Ethics Committee Apollo hospitals Chennai |
Submittted/Under Review |
Ethics Committee Apollo hospitals international limited Gandhinagar |
Approved |
Ethics Committee Apollo hospitals international limited Hyderabad |
Approved |
Ethics Committee Apollo hospitals Mysore |
Approved |
Ethics Committee Seth GS Medical College & KEM Hospital Mumbai |
Submittted/Under Review |
Institutite Ethics Committe AIIMS New Delhi |
Submittted/Under Review |
The Institutional Ethics committee B J Medical college & civil hospital ahmedabad |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
H1N1 Influenza |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Intervention |
H1N1-09 Influenza Virus-Like Particle (VLP) Vaccine |
0.5 ml Intramuscular injection of H1N1-09 influenza VLP vaccine (15µg HA of A/California/04/2009/H1N1) on Day 0 (SINGLE DOSE) |
Comparator Agent |
Placebo |
0.5 ml Intramuscular Injection on day 0 (SINGLE DOSE) |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
64.00 Year(s) |
Gender |
Both |
Details |
•Healthy volunteers of either sex between 18-64 years of age, inclusive
•Informed consent must be obtained from the volunteer prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol.
|
|
ExclusionCriteria |
Details |
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period
•Receipt of any other licensed influenza vaccines or investigational influenza vaccine within 6 months prior to enrollment in this study or expected receipt of any vaccination before the final immune response blood collection
•History of hypersensitivity to any component of inactivated influenza vaccines
•Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to the administration of the study vaccine (inhaled & topical steroids are allowed)
•Use of systemic glucocorticoids within one month prior to randomization
•Any clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by history, physical examination or laboratory screening tests
•Screening serum transaminase or alkaline phosphatase more than 3 times of ULN, creatinine and total bilirubin 1.5 times of ULN, Hgb 10 gm/dl, or BMI 28
•Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
•Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination
•Administration of immunoglobulin and/or any blood products within the three months preceding the administration of the study vaccine or during the study
•Acute illness of moderate or severe intensity at the time of enrollment, including any illness associated with fever ³100.5 0F
•Any congenital abnormalities, including hemglobinopathies, which could increase the risk of influenza complications
•History of any neurological disorders or seizures (with the exception of febrile seizures during childhood) related to an underlying immune disease or disorder, such as but not limited to: multiple sclerosis, lupus, Guillain-Barre syndrome.
•Women who are found to have a positive urinary pregnancy test; pregnant or lactating history or physical examination, or planning to become pregnant or to discontinue contraceptive precautions within 60 days of enrollment in this study
•Volunteers found positive in drugs of abuse test
•Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months
•Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Pharmacy-controlled Randomization |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
immunogenicity of H1N1-09 influenza VLP vaccine |
Seroconversion rate (Time frame: 22 days post-vaccination)
Seroprotection rate (Time frame: 22 days post-vaccination)
Mean fold-rise (Time frame: 22 days post-vaccination) |
|
Secondary Outcome
|
Outcome |
TimePoints |
safety and tolerability of H1N1-09 influenza VLP vaccine |
Solicited adverse events (Time frame: 7 days post-vaccination)
Unsolicited adverse events (Time frame: 22 days post-vaccination)
|
|
Target Sample Size
|
Total Sample Size="450" Sample Size from India="450" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
01/07/2014 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
Brief Summary
|
Cadila Pharmaceuticals Limited, India has successfully tested VLP-based H1N1-09 pandemic influenza vaccine in preclinical models and phase-I/II study (2012-2013). Based on this, present study is the Phase-III trial involving H1N1-09 influenza VLP Vaccine containing strain A/California/04/2009/H1N1 to be conducted among larger population at multicenters across India |